- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511012
Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification (LOBACOM)
July 12, 2023 updated by: University Hospital, Brest
- Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
- The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
- This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
- The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement coordination defect". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
- The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
- Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
- The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
- This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
- The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement control impairment". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
- The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.
LoBaCoM is a monocentric, exploratory prospective study.
The purpose is to define a kinematic (angular) threshold corresponding to an anomaly detected clinically by three therapists for each test.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vincent CREAC'H
- Phone Number: +33(0)298017935
- Email: vincent.creach@univ-brest.fr
Study Locations
-
-
Finistère
-
Brest, Finistère, France, 29609
- Recruiting
- CHU de Brest
-
Contact:
- Vincent CREAC'H
- Phone Number: +33(0)298017935
- Email: vincent.creach@univ-brest.fr
-
Sub-Investigator:
- Marine BOURHIS
-
Sub-Investigator:
- Fanny GARGADENNEC
-
Sub-Investigator:
- Thimothée HOUGRON
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged more than 18 years
- Common low back pain with medical prescription for rehabilitation
- Signed consent
- Be affiliated to a social security scheme
- Be able to perform the lumbar motion control failure tests
Exclusion Criteria:
- Body Mass Index greater than 30 (obesity)
- Person who does not understand French
- Pregnant woman
- Refusal to participate
- Volunteer under guardianship or curatorship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: motion control fault testing
Each patient make six motion control fault tests in the same order :
This tests are performed three times. |
Patients make 6 motion control fault tests, in the same order.
Each test is performed three times
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of compensation motion : "waiters bow" test
Time Frame: Day 0
|
Lumbar flexion measured for test number 1 "waiters bow".
Patients are filmed during the test.
Videos are watched by three physiotherapists.
They going to establish a diagnostic normal or abnormal
|
Day 0
|
Range of compensation motion : "pelvic tilt" test
Time Frame: Day 0
|
thoracic flexion measured for test number 2 "pelvic tilt".
Patients are filmed during the test.
Videos are watched by three physiotherapists.
They going to establish a diagnostic normal or abnormal.
|
Day 0
|
Range of compensation motion : "One leg stance" test
Time Frame: Day 0
|
Pelvic shift measured for test number 3 "One leg stance ".
Patients are filmed during the test.
Videos are watched by three physiotherapists.
They going to establish a diagnostic normal or abnormal.
|
Day 0
|
Range of compensation motion : "sitting knee extension" test
Time Frame: Day 0
|
Lumbar flexion measured for test number 4 "sitting knee extension".
Patients are filmed during the test.
Videos are watched by three physiotherapists.
They going to establish a diagnostic normal or abnormal.
|
Day 0
|
Range of compensation motion : "rocking 4 point kneeling" test
Time Frame: Day 0
|
Lumbar flexion and extension measured for test number 5 "rocking 4 point kneeling ".
Patients are filmed during the test.
Videos are watched by three physiotherapists.
They going to establish a diagnostic normal or abnormal.
|
Day 0
|
Range of compensation motion : "prone knee bend" test
Time Frame: Day 0
|
Lumbar extension measured for test number 6 "prone knee bend".
Patients are filmed during the test.
Videos are watched by three physiotherapists.
They going to establish a diagnostic normal or abnormal
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speed of execution for test 1
Time Frame: Day 0
|
It is measured with a camera.
The camera can film one hundred pictures per second.
Speed of execution is measured in seconds.
|
Day 0
|
Speed of execution for test 2
Time Frame: Day 0
|
It is measured with a camera.
The camera can film one hundred pictures per second.
Speed of execution is measured in seconds.
|
Day 0
|
Speed of execution for test 3
Time Frame: Day 0
|
It is measured with a camera.
The camera can film one hundred pictures per second.
Speed of execution is measured in seconds.
|
Day 0
|
Speed of execution for test 4
Time Frame: Day 0
|
It is measured with a camera.
The camera can film one hundred pictures per second.
Speed of execution is measured in seconds.
|
Day 0
|
Speed of execution for test 5
Time Frame: Day 0
|
It is measured with a camera.
The camera can film one hundred pictures per second.
Speed of execution is measured in seconds.
|
Day 0
|
Speed of execution for test 6
Time Frame: Day 0
|
It is measured with a camera.
The camera can film one hundred pictures per second.
Speed of execution is measured in seconds.
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2022
Primary Completion (Estimated)
December 15, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
August 19, 2022
First Submitted That Met QC Criteria
August 19, 2022
First Posted (Actual)
August 22, 2022
Study Record Updates
Last Update Posted (Actual)
July 13, 2023
Last Update Submitted That Met QC Criteria
July 12, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC22.0128
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest University Hospital.
Requestors will be required to sign and complete a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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